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Completed

NCT Number: NCT03842514

Food Additives - Do Processed Diets Impact on Gut and Metabolic Health

This dietary intervention study will assess the effect in healthy human volunteers of an E number which is a food additive and commonly used and consumed emulsifier, on gut function, gut inflammation and glucose metabolism. We will be using a powdered soy lecithin product in the food to compare a diet with and without this ingredient.

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Key information

Conditions

Gut Health Metabolic Health

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

About this study

A dietary intervention study to investigate the effect, in healthy human volunteers, of dietary lecithin (soy lecithin), a commonly used/consumed emulsifier, on markers of gut function particularly bacterial translocation (assessed by measure of venous blood bacterial DNA, circulating lipopolysaccharide [LPS] binding protein and soluble CD14), gut inflammation (assessed by measurement of faecal calprotectin), gut microbiota activity/composition (faecal short-chain fatty acid [SCFA] profile and bacterial diversity [16S ribosomal RNA genes]) and glucose metabolism (measured by oral glucose tolerance test [OGGT], plasma fasted lipids and insulin).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ranging from 27-40 kg/m2

Exclusion criteria

  • Antibiotic use within the past 3 months (due to impact on gut microbiota)
  • Current Statin use
  • Current Aspirin use
  • Chronic inflammatory disorders (including rheumatoid arthritis, inflammatory bowel disease)
  • Food allergies or self-reported food sensitivity or intolerance
  • Diagnosis of diabetes
  • Pregnant or breastfeeding
  • Unsuitable veins for blood sampling
  • Inability to speak, read and understand English
  • Unable to comply to alcohol-free diet for 5 weeks
  • Consumption of nutrition supplements
  • Soy allergy or intolerance.

Treatment and study plan

Soya lecithin

Dietary Supplement

The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices

Primary outcomes

  1. Change in bacterial translocation

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

    Assessment of change in bacterial translocation by venous blood bacterial DNA measured as responding to pre and post dietary treatment as gene copy number per ml but using more validated universal qPCR primer sets (including total bacteria, phyla- and class-specific primers)

Secondary outcomes

  1. Faecal calprotectin

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

  2. Faecal volatile organics compounds

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

  3. Faecal short chain fatty acids

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

  4. Faecal bacterial 16S rRNA gene sequencing

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

  5. Plasma highly sensitive C-reactive protein

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

  6. Plasma soluble CD14 and LPS binding protein

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

  7. Plasma fasting blood glucose and up to 3 hours after OGTT

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

  8. Plasma fasted insulin profile and up to 2 hours postprandial OGTT

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

  9. Plasma fasting lipid profile

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

    Triglycerides, high and low-density cholesterol will be assessed by Kone automated analyser

  10. Plasma trimethylamine-N-oxide (TMAO)

    Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • Medical Research Council
  • University of Liverpool

Registry information

Official study title

Investigation of the Effects of Dietary Lecithin on Intestinal Permeability, Bacterial Translocation, Microbiota and Glucose Metabolism

Acronym: FADiets

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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